Non Invasive Breath Based Acetone-meter- Easy Check
Primary Purpose
Type 1 Diabetes
Status
Terminated
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Easy Check
Sponsored by
About this trial
This is an interventional supportive care trial for Type 1 Diabetes focused on measuring Glucose monitoring, non-invasive glucometer, Self glucose monitoring
Eligibility Criteria
Inclusion Criteria:
- Signing an inform consent form
- Type 1 diabetes diagnosed at least 12 months prior to study inclusion
- Males aged > 18 years old
- 23< BMI < 28 (segment 1 only)
- Treatment with insulin pump (segment 2 only)
- Willing to perform all study related procedures
Exclusion Criteria:
- Psychiatric disorder
- Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease
- Patients who are not willing or are not capable of performing the protocol requirements
- Participating in another study that includes investigational drug or investigational equipment
- Patients who are under low carbohydrate diet
- Patients who are known as heavy alcohol drinkers
Sites / Locations
- Schneider Children's Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Easy Check versus reference glucometer and blood ketone meter
Arm Description
Collection of paired measurements of capillary blood glucose using reference method (approved glucometer)and blood beta Hydroxybutyrate (approved ketone meter) and data generated by the non invasive study device
Outcomes
Primary Outcome Measures
correlation between the acetone values generated by study device and blood beta Hydroxybutyrate
correlation between the acetone values generated by study device and blood glucose
correlation between the acetone values generated by study device and HbA1c
correlation between the acetone values generated by study device and oxygen
Secondary Outcome Measures
Clarke Error Grid (segment 1 only)
The Clarke Error Gride breaks down a scatter plot of a reference glucose meter and an evaluated glucose meter into five regions:
values within 20% of the reference meter, values outside of 20% but would not lead to inappropriate treatment,points leading to unnecessary treatment,points indicating a potentially dangerous failure to detect hypoglycemia or hyperglycemia and points that would confuse treatment of hypoglycemia for hyperglycemia and vice-versa.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01530347
Brief Title
Non Invasive Breath Based Acetone-meter- Easy Check
Official Title
Assessing Feasibility of Non-invasive Breath Based Acetone Meter -Easy Check- Relative to Finger Capillary Blood Glucose and Beta Hydroxybutyrate Reference
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Per sponsor decision to stop the development of the study device
Study Start Date
March 2012 (Actual)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Segment 1- this segment will include two main steps:
Step 1-Calibration: During this step we plan to collect paired measurements of capillary blood glucose using reference method and data generated by the non invasive study device. Samples will be obtained at specific time points during 4 hours: at fasting, and after consuming standard liquid meal at 60, 120, 180 and 240 minutes. At each time point capillary blood glucose will be measured using the invasive reference method. The paired reference and study device data will be analyzed using multivariate regression model to formulate a calibration algorithm model. This model will convert the acetone values measured by study device to blood glucose values.
step 2-Validation: During this segment the second step of this segment we plan to evaluate the validity and reliability of the non-invasive breath-based glucometer compared to standard invasive reference glucometer. Results will be compared using a Clark error grid.
Segment 2- During this segment we plan to collect paired measurements of capillary blood glucose beta Hydroxybutyrate using reference method and acetone values generated by the non invasive breath based study device. Samples will be obtained at specific time points during 4 hours after overnight fasting, while basal insulin will be suspended, which is accepted to produce ketosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Glucose monitoring, non-invasive glucometer, Self glucose monitoring
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Easy Check versus reference glucometer and blood ketone meter
Arm Type
Experimental
Arm Description
Collection of paired measurements of capillary blood glucose using reference method (approved glucometer)and blood beta Hydroxybutyrate (approved ketone meter) and data generated by the non invasive study device
Intervention Type
Device
Intervention Name(s)
Easy Check
Intervention Description
Collection of paired measurements of capillary blood glucose using reference method and data generated by the non invasive study device. Samples will be obtained at specific time points during 4 hours: at fasting, and after consuming standard liquid meal at 60, 120, 180 and 240 minutes.
Primary Outcome Measure Information:
Title
correlation between the acetone values generated by study device and blood beta Hydroxybutyrate
Time Frame
up to 30 weeks
Title
correlation between the acetone values generated by study device and blood glucose
Time Frame
up to 30 weeks
Title
correlation between the acetone values generated by study device and HbA1c
Time Frame
up to 30 weeks
Title
correlation between the acetone values generated by study device and oxygen
Time Frame
up to 30 weeks
Secondary Outcome Measure Information:
Title
Clarke Error Grid (segment 1 only)
Description
The Clarke Error Gride breaks down a scatter plot of a reference glucose meter and an evaluated glucose meter into five regions:
values within 20% of the reference meter, values outside of 20% but would not lead to inappropriate treatment,points leading to unnecessary treatment,points indicating a potentially dangerous failure to detect hypoglycemia or hyperglycemia and points that would confuse treatment of hypoglycemia for hyperglycemia and vice-versa.
Time Frame
up to 30 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signing an inform consent form
Type 1 diabetes diagnosed at least 12 months prior to study inclusion
Males aged > 18 years old
23< BMI < 28 (segment 1 only)
Treatment with insulin pump (segment 2 only)
Willing to perform all study related procedures
Exclusion Criteria:
Psychiatric disorder
Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease
Patients who are not willing or are not capable of performing the protocol requirements
Participating in another study that includes investigational drug or investigational equipment
Patients who are under low carbohydrate diet
Patients who are known as heavy alcohol drinkers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moshe Phillip, Prof
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider Children's Medical Center
City
Petah- Tikva
ZIP/Postal Code
49202
Country
Israel
12. IPD Sharing Statement
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Non Invasive Breath Based Acetone-meter- Easy Check
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